FDA recall Z-0342-2023

Bio-Rad Laboratories, Inc. · Class II · device

Product

CMV IgM EIA, in vitro diagnostic.

Reason for recall

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

Distribution

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

Key facts

Status
Ongoing
Initiation date
2022-10-19
Report date
2022-12-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2023